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NCT Number: NCT01815164

Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome

Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions. Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post treatment BOLD attenuation in both anterior and posterior insula during high intensity distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post differences for the low distension and for the two expectation conditions were almost exclusively seen in the HYP group. For all responders there was a significant correlation between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior insula. Following treatment, the brain response to distension was similar to that observed in HCs, suggesting that the treatment had a normalizing effect on the central processing abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced perception of visceral stimuli in IBS can be normalized by psychological interventions. Symptom improvement in the treatment groups may be mediated by different brain mechanisms.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Rome III Female Age 20-60 Swedish speaking Right-handed

Exclusion criteria

Central acting medication IBD Psychiatric diseases Abdominal surgery NictoinePacemaker Prosthesis Metal in the brain Claustrophobia Large tattoo

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Treatment and study plan

Hypnotherapy

Behavioral

Gut-directed hypnotherapy administered by an experienced hypnotherapist.

Educational intervention

Behavioral

Educational intervention vith education regarding Irritabel bowel Syndrome.

Primary outcomes

  1. Irritable Bowel Syndrome Symptom Severity Scale

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Effect of Hypnotherapy and Educational Intervention on Brain Response to Visceral Stimulus Perception in the Irritable Bowel Syndrome

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 20, 2013
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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